A healthy volunteer is considering participating in a research study testing a new vaccine for Ebola. He has left his glasses at home and he is unable to read the informed consent form. According to ICH E6, who must be present during the discussion of informed consent?

According to ICH E6 4.8.9, in case a volunteer is not able to read informed consent form, an impartial witness has to be present during the entire discussion. The consent form is given to the volunteer and it is also read out loud for the volunteer to understand. After the volunteer signs the consent form, the witness also has to sign and date it. This signature means that the witness agrees that the information in consent form was explained properly to the volunteer and he or she has consented to it.

lheduardomarques lheduardomarques · Answer 2 · 2022-03-10T11:34:27+01:00

According to ICH E6, the legal representative must be present during the discussion of informed consent.

ICH E6

4.8.4 None of the oral and written information concerning the trial, including the written informed consent form, should contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.

With this information, we can conclude that, according to ICH E6, the legal representative must be present during the discussion of informed consent.

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